Shands Hospital at the University of Florida
Gainesville, Florida, 32610, United States
Completed
NCT Number: NCT01765205
Newborn Screening for Critical Congenital Heart Disease
Previous studies have examined the usefulness of pulse oximetry or oxygen saturation to screen for left-sided cardiac lesions. These studies have shown that the occurrence of critical congenital cardiac malformations among asymptomatic newborns is high; the technique of pulse oximetry is reliable for detection of ductal dependant left-sided lesions, simple to operate(requires little time and can be done in the newborn nursery) and is cost effective; there is effective follow-up test (heart ultrasound) and available interventions have an effect on outcome for diagnosed newborns. The importance of this research project is to examine the overall helpfulness of measuring oximetry in newborn infants using somatic oximetry, as well ast to prepare for a population based study in the state of Florida.
Completed
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Conditions
Age range
12 hour–2 week
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
This study will evaluate up to 50 unaffected newborns and up to 10 known congenital heart disease (CHD) newborns using a new oximetry system. This system is interfaced to a laptop computer which computes the difference between central and lower extremity peripheral values, upper and lower body peripheral values, and records all data. This information may differentiate unaffected newborns and CHD newborns, and determine the effectiveness of pulse oximetry as a newborn screening for congenital cardiovascular malformations.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male or female subjects aged 12 hours -2 weeks.
- Newborns with identified congenital heart disease or newborns without identified congenital heart disease.
- Congenital Heart Diagnosis: Total Anomolous Pulmonary Venous Return (TAPVR); Atrio-ventricular Septal Defect ( AVSD); Coarctation of the Aorta; Critical Aortic Stenosis; other cyanotic legions including Hypoplastic Left Heart Syndrome ( HLHS)
Exclusion criteria
- Have any concurrent condition which, in the opinion of the investigator, would make the subject unsuitable for the study.
Treatment and study plan
Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter
DeviceUp to 50 healthy infants and up to 10 infants with CHD will receive the pulse oximetry using the INVOS Cerebral/Somatic Oximeter for 15 minutes to determine the effectiveness to measure somatic oxygen saturation. The pulse oximeter will be placed on the infants forehead with a hat and around the infants thigh to measure oxygen saturation.
Other names: Healthy Newborns with Pulse oximetry
Primary outcomes
-
To measure the oxygen saturation using pulse oximetry.
Time frame: Baseline
The oxygen saturation will be measured by pulse oximetry on an infant's skin on the forehead and thigh. These two numbers will be recorded as whole numbers on the machine and will be compared to both groups of infants.
Sponsors and collaborators
Lead sponsor
University of Florida
Other
Registry information
Official study title
The Efficacy of Newborn Screening for Critical Congenital Heart Disease
Important dates
- Study start
- 2010
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jan 10, 2013
- Registry last updated
- Mar 14, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.